Dose Escalation, Safety and Pharmacokinetic, First in Man Study, of SAR566658 Administered as a Single Agent by Intravenous Infusion Every 3 Weeks in Adult Patients With DS6-positive and Refractory Solid Tumors
The study consists in a period for screening (maximum length of 3 weeks), a treatment phase
with 21-day study treatment cycles. Patients may continue treatment until disease
progression, unacceptable toxicity, or willingness to stop. There will be a 30-day follow-up
visit after the last dose of study treatment administration.
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Assessment of investigational product (IP) related dose limiting toxicities (DLTs) observed at first cycle
3 weeks
Yes
Clinical Sciences & Operations
Study Director
Sanofi
United States: Food and Drug Administration
TED10499
NCT01156870
September 2010
April 2015
Name | Location |
---|---|
Investigational Site Number 840001 | San Antonio, Texas 78229 |
Investigational Site Number 840002 | Cincinnati, Ohio 45267-0542 |